MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CRYO DECOMPRESSION TUBE

Model Number	2000181
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up, steirs endoscopy learned that the patient presented with adenocarcinoma, and required dilation of a structured area of the esophagus for passage of the cryo decompression tube.There were no visible tears in the mucosa/tumor, however there was mild bleeding following the dilation and the doctor elected to continue the procedure.The procedure was completed successfully, and the patient was discharged.A steris product specialist was present during the procedure.No issues with the function or operation of the trufreeze system were noted.Approximately thirteen days later, the patient was treated at a different hospital where the perforation was detected.The patient was given antibiotics and a stent.The doctor who performed the initial procedure stated that the perforation was likely due to a complication with the procedure.The steris product specialist has contacted the doctor requesting additional information in addition to offering in-service training on the proper use and operation of the trufreeze system.To date, we have not received a response.The cryo decompression tube was not returned for evaluation, and the cause of the reported issue cannot be determined.The instructions for use state (p.3), "the physician should carefully consider patient eligibility for cryospray ablation (i.E.,cryosurgery and associated gas pressure), including patient presentation, medical history, co-morbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray." there have been no other complaints associated with this lot.A follow-up will be submitted when additional information become available.
Event or Problem Description
The user facility reported that a perforation was detected in a patient approximately thirteen days after undergoing a procedure which included use of trufreeze cryospray therapy.The procedure was completed successfully.The patient sought and received additional medical intervention (antibiotics, stent).
Additional Manufacturer Narrative
A steris product specialist offered in-service training on the proper use and operation of the trufreeze system; however, the doctor declined.No additional issues have been reported.

• Brand Name: CRYO DECOMPRESSION TUBE
• Common Device Name: CRYO DECOMPRESSION TUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060
• MDR Report Key: 17021843
• Report Number: 1528319-2023-00018
• Device Sequence Number: 7555339
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: 00724995199210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Model Number: 2000181
• Device Catalogue Number: 2000181
• Device Lot Number: 16FR CDT -2519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown