MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES

Model Number	FG 1012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bradycardia may be procedure-related or device-related.Bradycardia may occur secondary to ablation because of the proximity of the esophagus to the vagus nerve.Vagal stimulation may result from distention by the balloon, the ablation itself, or anesthetic.The data from the device was downloaded and reviewed.A total of 7 complete ablations were performed followed by a partial treatment ended early.At the end of the procedure there is an error for high balloon pressure where pressure suddenly spiked.The root cause of this pressure is undetermined.The controller was run with a known working catheter.A total of three 8-second ablations were performed and no issues were noted with controller functionality.Controller performed as intended.
Event or Problem Description
C2 therapeutics became aware of an event on (b)(6) 2017 a commercial patient with hgd experienced bradycardia during a cryoballoon procedure.There were 8 ablations performed with the cryoballoon system.The patient was bradycardic into the 20-30s, the patient was then given atropine which resolved the bradycardia.The patient's hemodynamics stabilized and he woke up from anesthesia without complications.The patient went home on the same day as scheduled.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, ste 1; redwood city CA 94063
• MDR Report Key: 6953223
• Report Number: 3008780134-2017-00015
• Device Sequence Number: 19110435
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 00854924006125
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K161202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 02/24/2018
• Device Model Number: FG 1012
• Device Lot Number: 08232017-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/16/2017
• 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