MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. C2 CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT AND ACCESSORIES

Model Number	FG-1012, FG-1009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catheter was not returned.The data from the returned controller was downloaded and analyzed.During the procedure, 6 complete, 10-second ablations were performed.There were 6 errors for high balloon pressure (4.5 psig), confirming the complaint.The returned controller was tested under simulated use conditions.Four complete ablations were successfully performed with no device functionality issues.The error reported was not replicated, and the root cause is inconclusive.As determined by the physician, the patient's difficulty swallowing is unrelated to the device.
Event or Problem Description
During the ablation procedure on (b)(6) 2016, 6 ablations of 10 seconds each were completed successfully.On ablation 7, the balloon deflated prematurely after 2 to 3 seconds (2 attempts).There was no patient injury reported.On (b)(6) 2016 during telephone follow-up, the patient reported difficulty swallowing.The patient was not hospitalized, but his medication and diet were changed.On (b)(6) 2016, the patient was able to eat soft food but was still having difficulty swallowing.The physician determined that this adverse event is mild in its intensity and is procedure related, not device related.

• Brand Name: C2 CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• MDR Report Key: 6190364
• Report Number: 3008780134-2016-00020
• Device Sequence Number: 10981966
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 00854924006125
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/23/2017
• Device Model Number: FG-1012, FG-1009
• Device Catalogue Number: FG-1012, FG-1009
• Device Lot Number: 09222016-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention