Events

Recall of Device Recall C2 CryoBalloon Ablation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C2 Therapeutics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76358
  • Event Risk Class
    Class 2
  • Event Number
    Z-1477-2017
  • Event Initiated Date
    2017-01-06
  • Event Date Posted
    2017-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152962
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    The controller cap of the c2 cyroballoon ablation system may crack as it is tightened onto the controller. that could compromise the integrity and result in damage to the controller cap.
  • Action
    Firm initially notified consignees who would be using the device in an upcoming procedure on January 6, 2017 to alert them of the potential issue and recommended that products with the affected cap not be used unless it can be checked by a C2 rep. Controller caps will be replaced within a few weeks; facilities will receive replacement caps by mail along with a shipping inventory label for return of those currently on hand. Formal recall letters were sent on January 19, 2017. Letters were sent by e-mail with receipt and read confirmation and follow up by phone call.

Device

Device Recall C2 CryoBalloon Ablation System
  • Model / Serial
    All lots distributed between June 23, 2016 and December 20, 2016: UPDATE - expanded to include product distributed from February 1 2016 through February 8, 2017. All numbers below have been updated. Lot numbers: Expiry dates 01122016-02 12-Jul-16; 06242016-01 1-Jan-2017; 11282016-03 2-Jun-2017; 01042016-03 14-Jul-16; 06292016-02 6-Jan-2017; 09202016-01 21-Mar-2017; 07062016-01 8-Jan-2017; 09222016-01 23-Mar-2017; 01252016-02 02-Aug-16; 07082016-02 13-Jan 2017; 09232016-01 28-Mar-2017; 01282016-01 01-Aug-16; 07082016-03 14-Jan-2017; 09232016-02 27-Mar-2017; 01292016-01 02-Aug-16; 07152016-01 21-Jan-2017; 09292016-01 4-Apr-2017; 02022016-03 09-Aug-16; 07152016-02 20-Jan-2017; 09302016-03 4-Apr-2017; 02082016-01 09-Aug-16; 07212016-01 25-Jan-2017; 10052016-02 19-Apr-2017; 02092016-02 11-Aug-16; 07252016-01 28-Jan-2017; 10142016-01 18-Apr-2017; 02112016-02 17-Aug-16; 07262016-01 9-Feb-2017; 10192016-01 24-Apr-2017; 02172016-02 25-Aug-16; 07282016-02 2-Feb-2017; 10212016-01 25-Apr-2017; 02222016-01 26-Aug-16; 08022016-01 17-Feb-2017; 10242016-01 26-Apr-2017; 03012016-01 04-Sep-16; 08032016-02 5-Feb-2017; 10262016-02 1-May-2017; 03072016-01 10-Sep-16; 08112016-01 16-Feb-2017; 10282016-02 8-May-2017; 03102016-02 15-Sep-16; 08232016-01 26-Feb-2017; 11022016-01 9-May-2017; 03152016-03 21-Sep-16; 08262016-01 2-Mar-2017; 11042016-01 10-May-2017; 03282016-02 29-Sep-16; 09022016-01 8-Mar-2017; 11092016-01 15-May-2017; 03292016-01 31-Sep-16; 09092016-01 14-Mar-2017; 11142016-02 16-May-2017; 09122016-02; 15-Mar-2017;  11152016-02 18-May-2017; 04012016-01 06-Oct-16; 09192016-01 19-Mar-2017; 11162016-01 21-May-2017; 09192016-02 21-Mar-2017; 11282016-02 30-May-2017; 04062016-01 12-Oct-16; 11302016-02 02-Jun-17; 12052016-01 08-Jun-17; 04112016-04 14-Oct-16; 12052016-03 06-Jun-17; 04142016-01 20-Oct-16; 12072016-01 09-Jun-17; 04202016-02 21-Oct-16; 12092016-01 13-Jun-17; 05022016-02 05-Nov-16; 12132016-01 19-Jun-17; 05092016-01 11-Nov-16; 12152016-02 20-Jun-17; 05162016-02 18-Nov-16; 01042017-01 04-Jul-17; 05232016-01 25-Nov-16; 01052017-03 19-Jul-17; 05272016-01 02-Dec-16; 01052017-04 19-Jul-17; 06022016-02 09-Dec-16; 01092017-01 12-Jul-17; 06102016-01 14-Dec-16; 01102017-01 18-Jul-17; 06152016-01 21-Dec-16; 01132017-01 18-Jul-17; 06172016-01 23-Dec-16; 01132017-03 17-Jul-17; 07282016-02 02-Feb-17.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.
  • Product Description
    C2 CryoBalloon Ablation System - Controller Cap. || C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device || The affected product is the Controller Cap component only, which is provided to || the customer already assembled onto the Controller. || Model number: FG-1012 || Product Usage: || The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
  • Manufacturer
    C2 Therapeutics, Inc.

Manufacturer

C2 Therapeutics, Inc.
  • Manufacturer Address
    C2 Therapeutics, Inc., 303 Convention Way Ste 1, Redwood City CA 94063-1415
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA