MAUDE Adverse Event Report: CSA MEDICAL, INC TRUFREEZE CRYOSPRAY SYSTEM; CRYOSURGICAL ACCESSORIES

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation (2001); Injury (2348)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is an (b)(6) year old man with esophageal adenocarinoma.Full thickness perforation occurred at the gastroesophageal junction/proximal stomach within 5 seconds of initiating cryospray.A 16 fr cdt was used.The console and catheter appeared to operate normally.The perforation was recognized immediately and treated appropriately.If endoscopic suturing was not available, this patient would have required emergent laparoscopy/laparotomy and surgical repair of this perforation.The only possible lapse in treatment protocol was the failure to assess the cdt for proper function once suction was turned on and prior to initiation of cryospray.Kinking of the 16 french cryo-decompression tube was noted after the perforation occurred but not seen prior.This could have developed with scope removal and may not have been present during the spray.No high-pressure alarm on the suction circuit occurred during the procedure.There does not appear to be any other possible user error or equipment malfunction during the procedure.The rapidity of the distension after such a short spray, and development of perforation, is unusual.The patient required icu level care and had a prolonged hospitalization due to abdominal pain but did not develop peritonitis or sepsis thanks to the rapid attention to the perforation.Summary: no death, serious injury (life-threatening requiring medical/surgical intervention to preclude permanent impairment), device may have contributed to the serious injury.

• Brand Name: TRUFREEZE CRYOSPRAY SYSTEM
• Common Device Name: CRYOSURGICAL ACCESSORIES
• Manufacturer (Section D): CSA MEDICAL, INC; 91 hartwell avenue; lexington MA 02421
• MDR Report Key: 8815620
• Report Number: 3010140265-2019-00003
• Device Sequence Number: 3027574
• Product Code: GEH
• UDI-Device Identifier: 00857068006099
• UDI-Public: 00857068006099
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160273
• 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): 06/17/2019

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: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: CC3-01
• Device Catalogue Number: 20-00177
• Device Lot Number: 8524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR