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Devices
Device Recall Catheter, C2 CryoBalloon Ablation System
Model / Serial
Lot Codes: 02132018-01 & 02162018-03
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distribution US nationwide.
Product Description
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Manufacturer
C2 Therapeutics, Inc.
1 Event
Recall of Device Recall Catheter, C2 CryoBalloon Ablation System
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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
Language
English
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