MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; ACTIVE VENTING CRYO DECOMPRESSION TUBE

Model Number	2000181
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the guidewire of the active venting cryo decompression tube went through the sheath causing a small cut to the patient's esophagus.No medical treatment was sought or administered.The procedure was cancelled and rescheduled for another day.
Additional Manufacturer Narrative
The active venting cryo decompression tube subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

• Brand Name: TRUFREEZE
• Common Device Name: ACTIVE VENTING CRYO DECOMPRESSION TUBE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4403586251
• MDR Report Key: 23622455
• Report Number: 1528319-2025-00107
• Device Sequence Number: 9962370
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: (01)00724995199210(17)270801(10)5525
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: (10)5525
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 08/01/2025
• 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