MAUDE Adverse Event Report: ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL ENSOETM; ESOPHAGEAL THERMAL REGULATION DEVICE

Model Number	ECD02-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Given the broad range of etiologies potentially causing esophageal hematomas, it is impossible to definitively determine the exact cause of this patient's injury with the provided information.While it is unlikely the ensoetm caused or contributed to the injury found in this patient, the possibility that abrasive trauma caused by the ensoetm may have caused or contributed to the injury cannot be ruled out.
Event or Problem Description
The patient underwent a radiofrequency cardiac ablation procedure for atrial fibrillation on (b)(6) 2022 that utilized the ensoetm to cool the esophagus during the procedure.Prior to the procedure, an endotracheal tube was used to secure the patient's airway, and placement of the endotracheal tube into the trachea was noted to be difficult.The initial attempt at placement of the endotracheal tube met resistance and was stopped.Multiple operators (including a student crna, crna, and anesthesiologist) attempted placement, and multiple attempts were required.Anesthesia notes stated that direct laryngoscopy offered only a grade 3 view in the cormack-lehane classification (where grading ranges from i to 4 with increasing difficulty of view of the glottis).Once endotracheal tube placement was successful, the ensoetm (our device) was inserted without difficulty into the esophagus.The patient was in the procedure room by 11:21am local time, the ensoetm was placed around 11:45am in the esophagus, access was obtained at 12:05pm, case completion was at 2:04pm, patient extubation was at 2:13pm, and the patient was out of the room by 2:29pm.Post-operatively, the patient noted 10/10 periumbilical pain requiring iv opiates and remained in the hospital for two nights.The pain resolved over a few days.On (b)(6) 2022, the patient noted difficulty swallowing (dysphagia).A ct scan demonstrated an intramural hematoma on the anterior side of the esophagus that extended from the level of the carina down to the gastroesophageal junction, and a gastrografin swallowing study the following day redemonstrated anterior compression of the esophageal lumen.The patient was kept in the hospital for monitoring while being taken off anticoagulant medications.He remained stable, tolerating oral liquids, and was discharged in good condition on (b)(6) 2023.A repeat fluoroscopic esophagram was performed as an outpatient on (b)(6) 2023, showing complete resolution and a normal appearing esophagus.

• Brand Name: ENSOETM
• Common Device Name: ESOPHAGEAL THERMAL REGULATION DEVICE
• Manufacturer (Section D): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 3440 s dearborn st #215-south; chicago IL 60616
• Manufacturer (Section G): ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL; 3440 s dearborn st #215-south; chicago IL 60616
• Manufacturer Contact: erik kulstad ; 3440 s dearborn st #215-south; chicago, IL 60616 ; 8885344873
• MDR Report Key: 16260226
• Report Number: 3010412492-2023-00001
• Device Sequence Number: 4778733
• Product Code: PLA
• UDI-Device Identifier: 00857915006180
• UDI-Public: (01)00857915006180(17)250321(10)199118722
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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 Expiration Date: 03/21/2025
• Device Model Number: ECD02-A
• Device Lot Number: 199118722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2022
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CINCINNATI SUB-ZERO SUB-ZERO BLANKETROL III.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 116 KG